Currently browsing posts about: FDA

Much of the report is about the need for better coordination of the food safety oversight responsibilities of the USDA (meat and poultry) and those of the FDA (everything else), not to mention the 13 other agencies that deal with aspects of food safety (the report provides a handy summary chart).

This report points out that both agencies

have mechanisms in place to facilitate interagency coordination on food safety that focus on specific issues, but none provides for broad-based, centralized collaboration…[Existing]mechanisms do not allow FDA, FSIS [USDA], and other agencies to look across their individual programs and determine how they all contribute to federal food safety goals. Nearly all the experts GAO interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The Food Safety Working Group (FSWG) served
as a centralized mechanism for broad-based food safety collaboration and resulted in a number of accomplishments, including improved coordination. However, the FSWG is no longer meeting…Without a centralized collaborative mechanism on food safety, there is no forum for agencies to reach agreement on a set of broad-based food safety goals and objectives.

The GAO complains that “for more than a decade, we have reported on the fragmented nature of federal food safety oversight.”

Actually, its complaints go back longer than that but here’s one from 1999:

I will have to go through my files but as I recall, the GAO started arguing for a single food safety agency sometime in the early 1990s. Political realities make that idea impossible. Instead, we have the Food Safety Working Group which seems to have stopped meeting.

It’s good the GAO is still on the case. We need better food safety oversight.

The issue: The White House is supposed to sign off or reply within 90 days, or formally request an extension. That’s not happening with menu calorie labeling or four others:

The Common or Usual Name for Raw Meat and Poultry rule: this refers to what you can call meat and poultry with added water, salt or other ingredients. The White House has been sitting on rule for review since April 30. Chicken producers love it. Some meat producers don’t. Here’s the initial proposal. It’s not clear whether or how it’s been altered.

USDA’s catfish inspection rule: Sent to the White House on May 30, this would implement a section of the 2014 farm bill that puts USDA, not FDA, in charge of catfish inspections (see previous post on this).

EPA’s Renewable Fuel Standard for 2014: This was sent August 22. The White House has not extended the review period. f the administration does take more time to officially complete its review, it could push the release of the rule governing how much ethanol needs to be mixed into gasoline for 2014 into 2015.

What’s going on? Politics, of course. But I can only speculate on what they might be.

I complained about the delay again four months ago, when rumors suggested that it was due to pressures from owners of pizza chains and movie theaters.

I quoted Politico Pro Agriculture on the White House-induced delay:

It was three months ago today that the White House first received FDA’s final rules for calorie labels on menus and vending machines, and by the Office of Management and budget’s own rules, that means time is up. Interagency review at OMB is supposed to take no more than 90 days before the final release of a measure, though that timeframe is often extended with little explanation on more controversial initiatives. While OMB is always mum on its schedule for rule reviews and releases, the end of the standard review period is sometimes a hint that something will be coming, if not today — the day before a long weekend — then soon. In the meantime, brush up on the issue here: http://politico.pro/1mKNcFr and here: http://politico.pro/1lzZLDe.

Come on White House OMB: the election is over. Let the FDA release the rules, please.

In 2010, President signed national menu labeling into law as part of the Affordable Care Act. The FDA proposed rules for labels in 2011, collected comments on the proposed rules, missed the July 3, 2014 deadline for issuing them, and by all reports sent them to the White House Office of Management and Budget last April.

The delay on releasing the final rules is widely reported to be due to lobbying efforts by industry groups. Known to have visited the White House and FDA officials are, among others, the Food Marketing Institute, Publix Super Market, Schnuck Markets, Kroger, Dominos Pizza, the Pizza Hut Franchise Association and Hungry Howies.

The Food Marketing Institute (FMI), the National Grocers Association (NGA) and Food Industry Association Executives (FIAE) held a lobbying “fly-in” to prevent FDA’s final menu labeling rule for calorie disclosures being extended to grocery stores.

A bill backed by the supermarket industry is the Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) which would require menu labeling only for establishments where the majority of business is derived from restaurant-type food.

As for whether menu labels do any good:

A CDC study reports that nearly all adults say they notice menu calorie labels, but only 57% say they use them.

In June I wrote about the FDA’s advice to pregnant women to avoid eating fish high in methylmercury. The advisory said to avoid the four fish highest in methylmercury: shark, swordfish, king mackerel, and tilefish.

In my book, What to Eat, I included a chapter on this very topic: “The Methylmercury Dilemma.” Here’s a quote:

Albacore tuna clearly belonged on the list of fish to avoid, but advice to restrict its consumption would surely affect the livelihoods of people who fish for, can, and sell tuna. Because hardly anyone knows the difference between one kind of tuna and another, fish companies worried that consumers would interpret advice to avoid albacore tuna as advice to avoid all tuna. Industry lobbyists urged the FDA to keep albacore tuna off the methylmercury advisory. Somehow, albacore tuna got left off.

That was in 2006. Consumer Reports tells us that pretty much all tuna is too high in methylmercury to be consumed by pregnant women. So this comment still seems relevant, no?

But back to Food Navigator, which collects in various pieces on the topic in one place. The “Radical overhaul” piece contains a summary of the major provisions. Others in the series are also useful (I’m quoted in some of them):

FDA proposals to list “added sugars” on the Nutrition Facts panel have already generated heated debate, so it’s perhaps unsurprising that its plan to include vitamin D is proving equally controversial…

A row is brewing over the merits of including ‘added sugars’ on the Nutrition Facts panel, with critics arguing that our bodies don’t distinguish between ‘naturally occurring’ and ‘added’ sugar – and neither should food labels – and supporters saying it will help consumers identify foods with more empty calories.

FDA proposals to change the way serving sizes are calculated to better reflect real-life eating behavior could encourage some people to eat even more unless the wording is changed, says one expert group.

While phosphorus is an essential nutrient found naturally in some foods such as egg yolk and milk, it is increasingly added to packaged foods via a raft of phosphorus additives, and some experts believe it should be listed on the Nutrition Facts panel.

“A 16-ounce drink and a two-ounce bag of potato chips are a single serving. If it’s bigger than that, from 200 to 400%, then you need to declare two columns of information—one for the serving size and one for the whole container.”

These proposals are highly technical and tough to slog through, so I tried to deal with the big picture.

July 27, 2014

TO: FDA

FROM: Marion Nestle, Professor of Nutrition, Food Studies and Public Health, New York University

RE: Comments: Serving size proposals, Docket No. FDA-2004-N-0258

In addressing the question of how to change serving size designations on food labels, FDA is faced with an impossible dilemma . Serving sizes, which are supposed to be based on amounts typically consumed from packaged products, are invariably perceived as recommendationsfor dietary intake.

To comment on each of the bold-face, italicized points:

Typically consumed: This information derives from dietary intake surveys which invariably underestimate actual intake, often by 30% to 40%.

Packaged foods: Food labels only appear on packaged foods. RACC amounts on packaged foods are often much lower than amounts served in restaurants or fast-food places (pizza is an obvious example). It is unclear whether amounts reported as consumed are from packages (with Nutrition Facts labels) or are from restaurants or fast-food places where portion sizes can be much higher than those for foods in packages.

Recommendation: Substantial anecdotal information suggests that people view labeled serving sizes as what they should be eating. They view the serving sizes as meaningless compared to the portion sizes of foods they are accustomed to eating.

What is well established is that overall calorie intake has increased since RACCs were established in 1993 and marketplace portion sizes have also increased.

Therefore, any increase in RACC runs the risk of being interpreted as a validation of current portion sizes and as a recommendation to eat more.

On the other hand, larger portions have more calories. These must appear on the label.

To address this dilemma, FDA should:

Make dual-column labeling mandatory for all food and beverage packages likely to be consumed in one sitting.

Require total calories in the package to be displayed on the front of the package.

Include a footnote explaining that the serving size is not meant as a recommendation

The FDA is taking comments on label proposals until August 1 (see info at end of post). Here’s mine on voluntary vitamin D labeling.

July 17, 2014

TO: FDA

FROM: Marion Nestle, Professor, New York University

RE: Proposed revision to Nutrition Facts Panel: VITAMIN D

This is to argue against permitting food companies to voluntarily label added “Vitamin” D on the Nutrition Facts panel. Doing so will not promote—and may possibly harm–public health.

Rationale

“Vitamin” D is not a vitamin; it is a hormone synthesized by the action of sunlight on skin. For this reason alone, it does not belong on the food label.

Vitamin D fortification must be understood as a form of hormone replacement therapy. As such, it raises questions about efficacy, dose, and side effects that should be asked about all such therapies.

Fortification and supplementation provide hormone Vitamin D by the oral route. This is not physiological. Active vitamin D is synthesized in the body through a series of reactions that begin with the action of sunlight on skin. Sunlight on skin produces ample Vitamin D, is regulated to promote synthesis as needed and avoid toxicity, and may lead to synthesis of other useful biological components; the unphysiologic oral route does not produce the same benefits.[i]

As a hormone, Vitamin D is found naturally in very few foods (e.g., fish); in them, it is present in small amounts. It is present in most foods as a result of fortification.

Permitting Vitamin D to be listed on food labels will encourage fortification, undoubtedly of foods that would not otherwise necessarily be recommended. To cite just one example: Yum Bunny Caramel Milk Spread fortified with vitamin D at 10% of the DV. This product is half sugars by weight, marketed as “a good source of calcium and vitamin D,” and clearly aimed at children. See: http://www.yumbunny.com/about-us. Whether such products should be considered “good sources” also deserves scrutiny.

Data from the Women’s Health Initiative also are consistent with largely inconclusive findings about hormone Vitamin D supplements and bone health.[v]

The Institute of Medicine (IOM) does not consider deficiency of Vitamin D to be a serious problem in the United States, except among certain population groups. Instead, because of widespread fortification and supplementation, it is concerned about the possibility of adverse consequences from overconsumption through supplementation or fortification.[vi]

Many scientific debates about hormone Vitamin D are as yet unresolved.[vii],[viii]

The lack of compelling research has permitted Vitamin D to become “trendy.” It is advertised on boxes of fortified cereals, has its own pro-supplement advocacy group, and generates millions in annual supplement sales.[ix]

In the absence of stronger evidence for benefit from fortification, and some evidence for possible adverse consequences, the FDA should not contribute to further commercialization of this misnamed hormone by permitting it to be listed on food labels.

Follow Marion

Next public appearance

Grand Rounds on the Future of Public Health, Mailman School of Public Health: “Food Politics 2015: From Personal Responsibility to Policy Advocacy,” This is the opening talk in a month-long series of lectures on obesity prevention. 4:00-5:30 Alumni Auditorium, 650 West 168th Street. Free and open to the public.